Application of Endotracheal Intubation and Laryngeal Mask Supreme Without Neuromuscular Blocker in Laparoscopic Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Asses to Peak Pressure
研究概览
简要总结
Laryngeal mask (LM) use in gynecological laparoscopy, contrary to widespread opinion, does not increase the incidence of gastric aspiration, the failure of ventilation or the risk of pulmonary aspiration . LM is presented as an alternative to endo tracheal tube (ETT) in spontaneous or positive pressure ventilation (PPV) . LM has gained widespread popularity in England for gynecological laparoscopic procedures. In addition in many previous studies LM has been successfully shown to provide appropriate lung ventilation in laparoscopic surgical interventions .Miller et al. compared the use of ETT, LM-P laparoscopic gynecological interventions and identified advantages to LM use. The most important of these advantages was that, contrary to tracheal tube techniques for laparoscopic surgeries, use of supraglottic laryngeal devices or neuromuscular blocker agents (NBA) were not required during placement. Thus for laparoscopic surgeries, compared with the ETT technique, without the need for supraglottic laryngeal devices or muscular relaxants, it is easily placed and reduces the time spent in the operating room.
Our aim; to compare the use of LM-S and ETT without neuromuscular agents for laparoscopic gynecological intervention with positive pressure ventilation from a surgical viewpoint and in terms of effect on ventilation parameters.
Secondary aim, comparison of airway morbidity with endotracheal intubation and supraglottic.
详细描述
This prospective, randomized and double-blind study received permission from "Dokuz Eylül University Medical Faculty Non-Interventional Research Ethics Committee" and after obtaining patients' informed consent, 100 patients with American society of anesthesiologists (ASA) classification group I-II, between 18-65 years, undergoing elective laparoscopic gynecological surgery were included.
Patients were divided into:
Group 1=>ETT (50 patients) Group 2=>LM-S (50 patients) Patients and surgeons performing the operation were not aware of which airway device was used. The patients in the groups were determined by block randomized methods.
Patients taken to the surgical room were given standard monitoring (non-invasive blood pressure measurements, electrocardiogram, and peripheral oxygen saturation measurements) before anesthesia induction. For preoperative sedation 0.02 mg/kg midazolam IV was administered.
Patients were preoxygenated with 6 L/min oxygen for 3 minutes through a face mask.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA classification group I-II
- •Between 18-65 years
- •Undergoing elective laparoscopic gynecological surgery
排除标准
- •Individuals with any neck and upper respiratory pathology
- •Individuals at risk of gastric content regurgitation/aspiration (previous upper gastrointestinal surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)
- •Individuals with low pulmonary compliance or high airway resistance (chronic lung diseases)
- •Obese patients (BMI >35)
- •Individuals with sore throat, dysphagia and dysphonia
- •Individuals with possibility or history of difficult airway
- •Operation time planned for more than 4 hours
结局指标
主要结局
Asses to Peak Pressure
时间窗: intraoperative period
peak pressure (cmH20) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device
Asses to Mean Pressure
时间窗: during procedure
mean pressures within the times below (cmH20) T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device
Asses to Ventilation Parameters
时间窗: intraoperative period
tidal volume (ml) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device
次要结局
- Ease of Orogastric Tube Placement Classification(Baseline)
- Incidence of Post-operative Sore Throat(Baseline)
- Quality of View According to Surgeon by Rate Scale(intraoperative period)
- Evaluation of Gastric Distention(Baseline)
- Haemodynamic Response to Insertion of Airway Device(Baseline)
研究者
Sule Ozbilgin
Anaesthesiology and Reanimation
Dokuz Eylul University